Pub Date : 2024-11-01DOI: 10.1016/j.jtho.2024.08.009
Joe Y. Chang MD, PhD, FASTRO, FACR, Vivek Verma MD
{"title":"Appreciate the Past, but Embrace the Present and Future: Historical Versus Modern Data of Stereotactic Ablative Radiotherapy for Early-Stage NSCLC","authors":"Joe Y. Chang MD, PhD, FASTRO, FACR, Vivek Verma MD","doi":"10.1016/j.jtho.2024.08.009","DOIUrl":"10.1016/j.jtho.2024.08.009","url":null,"abstract":"","PeriodicalId":17515,"journal":{"name":"Journal of Thoracic Oncology","volume":"19 11","pages":"Pages 1486-1488"},"PeriodicalIF":21.0,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142586241","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-01DOI: 10.1016/j.jtho.2024.08.023
Jennifer W. Carlisle MD, Rebecca D. Pentz PhD, Suresh S. Ramalingam MD
{"title":"Equipoise Is No Longer a Major Consideration in the Ethical Evaluation of Phase 3 Randomized Controlled Trials Involving Precision Oncology Approaches in NSCLC","authors":"Jennifer W. Carlisle MD, Rebecca D. Pentz PhD, Suresh S. Ramalingam MD","doi":"10.1016/j.jtho.2024.08.023","DOIUrl":"10.1016/j.jtho.2024.08.023","url":null,"abstract":"","PeriodicalId":17515,"journal":{"name":"Journal of Thoracic Oncology","volume":"19 11","pages":"Pages 1509-1511"},"PeriodicalIF":21.0,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142586274","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-01DOI: 10.1016/S1556-0864(24)02364-5
{"title":"Board of Directors","authors":"","doi":"10.1016/S1556-0864(24)02364-5","DOIUrl":"10.1016/S1556-0864(24)02364-5","url":null,"abstract":"","PeriodicalId":17515,"journal":{"name":"Journal of Thoracic Oncology","volume":"19 11","pages":"Page A3"},"PeriodicalIF":21.0,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142586347","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-01DOI: 10.1016/j.jtho.2024.08.020
Wenqin Wang PhD, Xiangzhi Li PhD, Dan Shan MD
{"title":"Critical Evaluation of Methodologic Approaches in ALK Tyrosine Kinase Inhibitor Research: Addressing Confounding Factors and Statistical Robustness","authors":"Wenqin Wang PhD, Xiangzhi Li PhD, Dan Shan MD","doi":"10.1016/j.jtho.2024.08.020","DOIUrl":"10.1016/j.jtho.2024.08.020","url":null,"abstract":"","PeriodicalId":17515,"journal":{"name":"Journal of Thoracic Oncology","volume":"19 11","pages":"Pages e64-e65"},"PeriodicalIF":21.0,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142587292","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-01DOI: 10.1016/j.jtho.2024.07.008
Jhanelle E. Gray MD , Aleksandra Markovets PhD , Thanyanan Reungwetwattana MD, MSc , Margarita Majem MD, PhD , Naoyuki Nogami MD, PhD , Nir Peled MD, PhD , Jong-Seok Lee MD , Byoung Chul Cho MD, PhD , Busayamas Chewaskulyong MD , Tom John MD, PhD , Ji-Youn Han MD, PhD , Martin Sebastian MD , Alexander Todd MSc , Yuri Rukazenkov MD, PhD , Carl Barrett PhD , Juliann Chmielecki PhD , Siow Ming Lee PhD, FRCP , Suresh S. Ramalingam MD , Ryan Hartmaier PhD
Introduction
EGFR tyrosine kinase inhibitor (EGFR-TKI)-sensitizing and -resistance mutations may be detected in plasma through circulating tumor DNA (ctDNA). Circulating tumor DNA level changes reflect alterations in tumor burden and could be a dynamic indicator of treatment effect. This analysis aimed to determine whether longitudinal EGFR-mutation ctDNA testing could detect progressive disease (PD) before radiologic detection.
Methods
This was a retrospective, exploratory ctDNA analysis in two phase 3 trials (FLAURA, NCT02296125; AURA3, NCT02151981). Patients had treatment-naïve (FLAURA) or EGFR-TKI pre-treated (AURA3) advanced NSCLC with EGFR mutations and on-study PD (RECIST [Response Evaluation Criteria in Solid Tumors]), with a baseline ctDNA result and EGFR-mutation ctDNA monitoring beyond Cycle 3 Day 1. Patients received osimertinib versus comparator EGFR-TKIs (FLAURA) or chemotherapy (AURA3). Outcomes included time from ctDNA PD to RECIST PD and the first subsequent treatment (FLAURA only).
Results
Circulating tumor DNA PD preceded or co-occurred with RECIST-defined PD in 93 out of 146 patients (64%) in FLAURA and 82 out of 146 patients (56%) in AURA3. Median time from ctDNA PD to RECIST-defined PD (mo) was 3.4 and 2.6 in the osimertinib and comparator EGFR-TKI arms (FLAURA) and 2.8 and 1.5 in the osimertinib and chemotherapy arms (AURA3). In FLAURA, the median time from ctDNA PD to the first subsequent treatment (mo) was 6.0 and 4.7 in the osimertinib (n = 51) and comparator EGFR-TKI arms (n = 70).
Conclusions
Among patients with EGFR mutation-positive advanced NSCLC receiving EGFR-TKI or chemotherapy with ctDNA data and RECIST-defined PD, ctDNA PD preceded/co-occurred with RECIST-defined PD in approximately 60% of cases. Longitudinal ctDNA monitoring may detect PD before radiologic PD.
{"title":"Longitudinal Analyses of Circulating Tumor DNA for the Detection of EGFR Mutation-Positive Advanced NSCLC Progression During Treatment: Data From FLAURA and AURA3","authors":"Jhanelle E. Gray MD , Aleksandra Markovets PhD , Thanyanan Reungwetwattana MD, MSc , Margarita Majem MD, PhD , Naoyuki Nogami MD, PhD , Nir Peled MD, PhD , Jong-Seok Lee MD , Byoung Chul Cho MD, PhD , Busayamas Chewaskulyong MD , Tom John MD, PhD , Ji-Youn Han MD, PhD , Martin Sebastian MD , Alexander Todd MSc , Yuri Rukazenkov MD, PhD , Carl Barrett PhD , Juliann Chmielecki PhD , Siow Ming Lee PhD, FRCP , Suresh S. Ramalingam MD , Ryan Hartmaier PhD","doi":"10.1016/j.jtho.2024.07.008","DOIUrl":"10.1016/j.jtho.2024.07.008","url":null,"abstract":"<div><h3>Introduction</h3><div>EGFR tyrosine kinase inhibitor (EGFR-TKI)-sensitizing and -resistance mutations may be detected in plasma through circulating tumor DNA (ctDNA). Circulating tumor DNA level changes reflect alterations in tumor burden and could be a dynamic indicator of treatment effect. This analysis aimed to determine whether longitudinal <em>EGFR</em>-mutation ctDNA testing could detect progressive disease (PD) before radiologic detection.</div></div><div><h3>Methods</h3><div>This was a retrospective, exploratory ctDNA analysis in two phase 3 trials (FLAURA, NCT02296125; AURA3, NCT02151981). Patients had treatment-naïve (FLAURA) or EGFR-TKI pre-treated (AURA3) advanced NSCLC with <em>EGFR</em> mutations and on-study PD (RECIST [Response Evaluation Criteria in Solid Tumors]), with a baseline ctDNA result and <em>EGFR</em>-mutation ctDNA monitoring beyond Cycle 3 Day 1. Patients received osimertinib versus comparator EGFR-TKIs (FLAURA) or chemotherapy (AURA3). Outcomes included time from ctDNA PD to RECIST PD and the first subsequent treatment (FLAURA only).</div></div><div><h3>Results</h3><div>Circulating tumor DNA PD preceded or co-occurred with RECIST-defined PD in 93 out of 146 patients (64%) in FLAURA and 82 out of 146 patients (56%) in AURA3. Median time from ctDNA PD to RECIST-defined PD (mo) was 3.4 and 2.6 in the osimertinib and comparator EGFR-TKI arms (FLAURA) and 2.8 and 1.5 in the osimertinib and chemotherapy arms (AURA3). In FLAURA, the median time from ctDNA PD to the first subsequent treatment (mo) was 6.0 and 4.7 in the osimertinib (n = 51) and comparator EGFR-TKI arms (n = 70).</div></div><div><h3>Conclusions</h3><div>Among patients with <em>EGFR</em> mutation-positive advanced NSCLC receiving EGFR-TKI or chemotherapy with ctDNA data and RECIST-defined PD, ctDNA PD preceded/co-occurred with RECIST-defined PD in approximately 60% of cases. Longitudinal ctDNA monitoring may detect PD before radiologic PD.</div></div>","PeriodicalId":17515,"journal":{"name":"Journal of Thoracic Oncology","volume":"19 11","pages":"Pages 1525-1538"},"PeriodicalIF":21.0,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141727319","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-01DOI: 10.1016/j.jtho.2024.08.006
Zhaoning Li MD, Xian Ye MD
{"title":"Stereotactic Body Radiation Therapy Without Pathologic Diagnosis: A Risky Approach","authors":"Zhaoning Li MD, Xian Ye MD","doi":"10.1016/j.jtho.2024.08.006","DOIUrl":"10.1016/j.jtho.2024.08.006","url":null,"abstract":"","PeriodicalId":17515,"journal":{"name":"Journal of Thoracic Oncology","volume":"19 11","pages":"Pages e71-e72"},"PeriodicalIF":21.0,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142587194","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-01DOI: 10.1016/j.jtho.2024.09.1427
Peter S.N. van Rossum MD, PhD, Nienke Wolfhagen MD, Ronald A.M. Damhuis PhD, José S.A. Belderbos MD, PhD
{"title":"An In-Depth Discussion on Dutch Prediction Models for Relevant Acute Toxicity and 90-Day Mortality After Stereotactic Body Radiotherapy for Stage I NSCLC","authors":"Peter S.N. van Rossum MD, PhD, Nienke Wolfhagen MD, Ronald A.M. Damhuis PhD, José S.A. Belderbos MD, PhD","doi":"10.1016/j.jtho.2024.09.1427","DOIUrl":"10.1016/j.jtho.2024.09.1427","url":null,"abstract":"","PeriodicalId":17515,"journal":{"name":"Journal of Thoracic Oncology","volume":"19 11","pages":"Pages e74-e77"},"PeriodicalIF":21.0,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142587197","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-01DOI: 10.1016/j.jtho.2024.08.022
Hedy L. Kindler MD , Adam Rosenthal MS , Dorothy J. Giroux MS , Anna K. Nowak M.B.B.S., PhD , Andrea Billè MD, PhD , Ritu R. Gill M.B.B.S., MPH , Harvey Pass MD , David Rice MD , Robert T. Ripley MD , Andrea Wolf MD, MPH , Kevin G. Blyth MD , Susanna Cedres MD, PhD , Valerie Rusch MD , Members of the IASLC Staging and Prognostic Factors Committee, Advisory Boards and Participating Institutions
Introduction
The International Association for the Study of Lung Cancer developed a global multicenter database to propose evidence-based revisions for the ninth edition of the TNM classification of pleural mesothelioma (PM). This study analyzes the M category to validate eighth edition M category recommendations.
Methods
Cases were submitted electronically or by transfer of existing institutional databases for patients with histologically or cytologically confirmed PM. The presence and number of metastases (single versus multiple) in each of eight organ systems were reported for patients with M1 disease at diagnosis. Overall survival (OS) was calculated by the Kaplan-Meier method. Differences in OS were assessed by log-rank test.
Results
Of 7338 submitted cases, 3598 were eligible and 3221 had sufficient data for clinical staging; 228 cases (7%) were M1. Median overall estimated survival was inferior for M1 compared with M0 patients: 10.5 months versus 21.5 months, respectively (p < 0.0001); estimated 1-year survival was 46% versus 71%, respectively. OS differences between M categories were preserved within histologic subgroups. Among 158 patients with organ-specific documentation of M1 disease, there was no statistically significant difference in OS between those with intrathoracic versus more distant metastatic disease (14.4 mo versus 10.9 mo, p = 0.64). No significant survival difference was detected between patients with metastatic disease in a single-organ system versus multiple-organ systems (12.6 mo versus 8.8 mo, p = 0.45).
Conclusions
This evidence-based analysis of the M category for PM conforms with the eighth edition M descriptors. No changes are proposed in the ninth edition of the mesothelioma M category.
导言:国际肺癌研究协会(IASLC)开发了一个全球多中心数据库,为第9版胸膜间皮瘤(PM)的肿瘤结节转移(TNM)分类提出循证修订建议。本研究分析了M分类,以验证第8版M分类的建议:方法:病例以电子方式提交,或从现有的机构数据库中调取经组织学或细胞学确诊的胸膜间皮瘤患者的资料。对于诊断时为M1疾病的患者,报告八个器官系统中每个系统是否存在转移灶以及转移灶的数量(单个或多个)。总生存期(OS)采用 Kaplan-Meier 法计算。OS 的差异通过对数秩检验进行评估:在提交的 7,338 个病例中,3,598 个符合条件,3,221 个有足够数据进行临床分期;228 个病例(7%)为 M1。与 M0 患者相比,M1 患者的中位总估计生存率较低:分别为 10.5 个月和 21.5 个月(p 结论:这是一项基于证据的 M 级分类分析:对 PM 的 M 级分类进行的循证分析符合第 8 版的 M 级描述。第9版的间皮瘤M分类没有提出任何变化。
{"title":"The International Association for the Study of Lung Cancer Mesothelioma Staging Project: Proposals for the M Descriptors in the Forthcoming Ninth Edition of the TNM Classification for Pleural Mesothelioma","authors":"Hedy L. Kindler MD , Adam Rosenthal MS , Dorothy J. Giroux MS , Anna K. Nowak M.B.B.S., PhD , Andrea Billè MD, PhD , Ritu R. Gill M.B.B.S., MPH , Harvey Pass MD , David Rice MD , Robert T. Ripley MD , Andrea Wolf MD, MPH , Kevin G. Blyth MD , Susanna Cedres MD, PhD , Valerie Rusch MD , Members of the IASLC Staging and Prognostic Factors Committee, Advisory Boards and Participating Institutions","doi":"10.1016/j.jtho.2024.08.022","DOIUrl":"10.1016/j.jtho.2024.08.022","url":null,"abstract":"<div><h3>Introduction</h3><div>The International Association for the Study of Lung Cancer developed a global multicenter database to propose evidence-based revisions for the ninth edition of the TNM classification of pleural mesothelioma (PM). This study analyzes the M category to validate eighth edition M category recommendations.</div></div><div><h3>Methods</h3><div>Cases were submitted electronically or by transfer of existing institutional databases for patients with histologically or cytologically confirmed PM. The presence and number of metastases (single versus multiple) in each of eight organ systems were reported for patients with M1 disease at diagnosis. Overall survival (OS) was calculated by the Kaplan-Meier method. Differences in OS were assessed by log-rank test.</div></div><div><h3>Results</h3><div>Of 7338 submitted cases, 3598 were eligible and 3221 had sufficient data for clinical staging; 228 cases (7%) were M1. Median overall estimated survival was inferior for M1 compared with M0 patients: 10.5 months versus 21.5 months, respectively (<em>p</em> < 0.0001); estimated 1-year survival was 46% versus 71%, respectively. OS differences between M categories were preserved within histologic subgroups. Among 158 patients with organ-specific documentation of M1 disease, there was no statistically significant difference in OS between those with intrathoracic versus more distant metastatic disease (14.4 mo versus 10.9 mo, <em>p</em> = 0.64). No significant survival difference was detected between patients with metastatic disease in a single-organ system versus multiple-organ systems (12.6 mo versus 8.8 mo, <em>p</em> = 0.45).</div></div><div><h3>Conclusions</h3><div>This evidence-based analysis of the M category for PM conforms with the eighth edition M descriptors. No changes are proposed in the ninth edition of the mesothelioma M category.</div></div>","PeriodicalId":17515,"journal":{"name":"Journal of Thoracic Oncology","volume":"19 11","pages":"Pages 1564-1577"},"PeriodicalIF":21.0,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142056017","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}